TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS, WITH RADIAL; LAPAROSCOPE, GENERAL
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Model Number VSP550EX |
Device Problems
Smoking (1585); Use of Device Problem (1670); Sparking (2595)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2022 |
Event Type
Injury
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Event Description
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The user facility reported to terumo cardiovascular that during vein harvesting, the lateral branches could not be blocked, and sparks were seen.As per the user facility, the operator used endoscopic vascular harvesting system to harvest the patient's saphenous vein and used the collector to block the lateral branches of the saphenous vein intraoperatively.After using the product for more than 10 minutes, it was found that the lateral branches could not be blocked and sparks were seen; therefore, the collector was hurriedly removed, and it was found that the smoldering area was charred.In the operating room, the operator turned on the power and found that the charred part of the collector would continue to emit smoke.Subsequently, the collector was replaced with another endoscopic vascular harvesting system and the lateral branches of the saphenous vein could be blocked normally.*there was a known insignificant delay in the procedure.*the product was changed out.*the surgery was completed successfully.
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Manufacturer Narrative
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Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.(b)(4).
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Manufacturer Narrative
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This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on december 16, 2022.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 10, 11, 3331, 120, 19).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation finding: 120 - electrical problem identified.Investigation conclusions: 19 - cause traced to user.The affected sample was inspected upon receipt to confirm a burned v-cutter.The condition of the returned sample did not allow for electrical testing.A retention sample was inspected to show no anomalies with the device and a fully intact v-cutter.The sample was electrically tested.No anomalies with the device were found and all electrical tests were within specification.During the manufacturing process, all vsp550 are visually inspected and tested for functionality and performance along with inspection for v-cutter mechanism, prior to packaging.Based on review of past complaints, cracked/fractured/burnt distal end of the v-cutter most likely resulted from excessive force applied to the distal end of the v-cutter during the procedure.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Search Alerts/Recalls
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